Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy: a Multicenter, Randomized, Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,607
- 试验地点
- 1
- 主要终点
- Bowel preparation adequate rate
研究概览
简要总结
The clinical purpose of this study was to investigate whether the adjuvant application of linaclotide in bowel preparation for colonoscopy could improve the quality of bowel preparation or reduce the dosage of laxatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 years old, male or female;
- •To undergo diagnostic, screening or monitoring colonoscopy;
- •Signed written informed consent;
排除标准
- •Severe cardiopulmonary insufficiency, renal failure or a history of stroke or myocardial infarction within six months;
- •History of abdominal or pelvic surgery;
- •Pregnant and lactating women;
- •BMI > 28, BMI < 18.5, inflammatory bowel disease, constipation (defecation less than 3 times in the last week, and laborious defecation, fecal sclerosis, low volume) or intestinal obstruction and other high-risk factors of intestinal preparation;
- •Abnormal coagulation function or taking antiplatelet or anticoagulant drugs within 7 days;
- •Warning symptoms and signs of colorectal cancer: hematochezia, melena, unexplained anemia, low body weight, abdominal mass, positive digital rectal test; or imaging and laboratory tests highly suspect colorectal cancer;
- •Colon polyps have been identified;
- •Stow score 7 (watery, no solid mass), diarrhea was considered;
- •Participation in other interventional clinical trials within 60 days.
研究组 & 干预措施
3L PEG + Linaclotide
Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution combined with 3-day linaclotide.
干预措施: 3L PEG + Linaclotide (Drug)
3L PEG alone
Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution without linaclotide.
干预措施: 3L PEG (Drug)
2L PEG + Linaclotide
Bowel preparation for colonoscopy was performed with 2L polyethylene glycol solution combined with 3-day linaclotide.
干预措施: 2L PEG + Linaclotide (Drug)
结局指标
主要结局
Bowel preparation adequate rate
时间窗: within 10 minute after viewing colonoscopy video.
The proportion of participants with all colon segment scores (right colon, transverse colon, left colon) were ≥ 2 according to Boston Bowel Preparation Scale (BBPS) .
次要结局
- Boston bowel preparation scale score(Within 10 minute after viewing colonoscopy video.)
- Endoscopists satisfaction with the quality of bowel preparation(Immediately after colonoscopy.)
- Bowel preparation excellent rate(Within 10 minute after viewing colonoscopy video.)
- Bowel preparation completion rate assessed by questionnaire survey(Immediately after questionnaire survey.)
- Subjects satisfaction rate assessed by questionnaire survey(Immediately after questionnaire survey.)
- Polyp detection rate(Immediately after colonoscopy.)
- Incidence of adverse events assessed by questionnaire survey(Immediately after questionnaire survey.)
- Adenoma detection rate(14 days after colonosopy.)
- Drug compliance in linaclotide group(Immediately after questionnaire survey.)
- Aronchick Scale(Within 10 minute after viewing colonoscopy video.)